- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03261687
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
24. august 2017 opdateret af: University of Bradford
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain : a Randomised Controlled Feasibility Study.
This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.
Twenty-three participants with diagnosed PGP, recruited at St George's Hospital London, were randomised into two groups (water or land exercise).
Each group received, four, once-weekly exercise sessions on land or water.
Exercise effects on PGP were measured using a variety of outcome measures.
Outcomes were assessed at baseline and post four weeks exercise.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
23
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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London, Det Forenede Kongerige, SW17 0QT
- St George's Hospital,
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
Participants were over eighteen years old, over twelve weeks pregnant and able to speak English.
Exclusion Criteria:
Participants were excluded from the study if they had uncontrolled blood pressure, placenta praevia, pre-eclampsia, obstetric cholestatsis, uncontrolled asthma, unstable respiratory or cardiac conditions, had open skin wounds or MRSA
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Water Exercise + advice
Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise).
Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.
|
general advice given to all subjects
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Eksperimentel: Land Exercise + advice
Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise).
Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.
|
general advice given to all subjects
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pelvic Girdle Pain Questionnaire (PGPQ)
Tidsramme: 4 weeks (pre and post intervention)
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A score change of 7 was set as a clinically significant difference
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4 weeks (pre and post intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale (VAS)
Tidsramme: 4 weeks (pre and post intervention)
|
score change of 1.5 was set as clinically significant
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4 weeks (pre and post intervention)
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Patient Specific Functional Score (PSFS)
Tidsramme: 4 weeks (pre and post intervention)
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score change of 1 was set as clinically significant
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4 weeks (pre and post intervention)
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Active Straight Leg Raise (ASLR).
Tidsramme: 4 weeks (pre and post intervention)
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score change of 1 was set as clinically significant
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4 weeks (pre and post intervention)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. maj 2016
Primær færdiggørelse (Faktiske)
31. december 2016
Studieafslutning (Faktiske)
31. januar 2017
Datoer for studieregistrering
Først indsendt
23. august 2017
Først indsendt, der opfyldte QC-kriterier
24. august 2017
Først opslået (Faktiske)
25. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRAS 198588
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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